A class-action suit claims that Boston Scientific knowingly used counterfeit material from China to manufacture vaginal mesh implants, resulting in bleeding, infections and other health problems.
Boston Scientific is facing yet another lawsuit over its vaginal mesh products. It’s the latest in a long string of suits filed against the medical device manufacturer over the controversial plastic mesh.
But this time Boston Scientific is accused of putting the health of thousands of women at risk by using counterfeit materials smuggled from China to manufacture its vaginal mesh implants.
According to the complaint filed in a federal court in West Virginia by Houston-based Mostyn Law, after the medical device maker lost its U.S. supplier of synthetic resin, it bought substandard tainted resin from a known counterfeiter in China and used that untested and unapproved material to produce its mesh implants.
“Boston Scientific knowingly sold a product that put women’s health and their lives at risk. It conspired with questionable suppliers in China to get material that it couldn’t get in the U.S. and went to great lengths to hide it,” Amber Mostyn, head attorney at the firm, said in a statement.
Mostyn Law is requesting class-action status for the lawsuit. The suit seeks unspecified damages for up to 55,000 women each year who had a vaginal mesh from the Massachusetts-based company implanted after September 2012.
The medical device manufacturer has refuted the allegations.
“At Boston Scientific, patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products,” spokesman Tom Keppeler said in a statement. “We don’t believe the case has merit and intend to vigorously defend these claims.”
Boston Scientific is just one manufacturer of the controversial vaginal mesh, which can be used to repair pelvic organ prolapse and bladder control problems in women. But many women have blamed the mesh for causing miscarriages, severe pelvic pain, bleeding, pain during sex and urinary issues.
Boston Scientific paid about $119 million in 2015 to settle roughly 3,000 of the more than 30,000 lawsuits it faces over its vaginal mesh implants, the Boston Globe reports.
In related news, the Food and Drug Administration recently strengthened requirements for vaginal mesh to address safety risks, reclassifying the medical device from class II (moderate-risk) to class III (which mainly includes high-risk devices). The FDA also now requires vaginal mesh manufacturers to submit a “premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of [pelvic organ prolapse].”
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